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“Residual Issues in Patentability Criteria in India & Overseas”. Dr. Gopakumar G. Nair Gopakumar Nair Associates ( [email protected] ) on 11 th July 2008 at Hotel Taj Krishna, Hyderabad . GNAs. Patent Policy. CONVERGENCE Indian & US Patent Laws are converging

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residual issues in patentability criteria in india overseas

“Residual Issues in Patentability Criteria in India & Overseas”

Dr. Gopakumar G. Nair

Gopakumar Nair Associates

([email protected])

on

11th July 2008

at

Hotel Taj Krishna, Hyderabad

GNAs

patent policy
Patent Policy

CONVERGENCE

Indian & US Patent Laws are converging

On substantive aspects of patentability

criteria.

GNAs

patentability criteria
Patentability Criteria

Novelty

- Prior art based

Indian Patent Offices – rely on prior art

USPTO now insists on Prior Art Disclosure as compulsory –

McKesson Information Solutn Inc v. Bridge Medical, Inc

When related prior art material disclosures are not made in the patent application and are not continuously intimated to the patent office thereafter, such a conduct is considered inequitable and the patent application is to be declared invalid and unenforceable. Incase of prior art materials, disclosures should be made in the patent application and as such should be communicated to the patent office as and when available to the patent applicant

GNAs

patentability criteria4
Patentability Criteria

Non-obviousness / inventive step

India liberal on obviousness

US was liberal on obviousness

Now tightening up after –

KSR vs. Teleflex

(SC 04-1350 decided April 30, 2007)

Pfizer vs. Apotex

(USCAFC 2006-1261 – May 21, 2007)

GNAs

patentability
Patentability

USA

“Anything under the sun involving manual intervention”.

INDIA

“INVENTIONS not PATENTABLE”

3(a) TO 3(p)

GNAs

non patentability
Non-patentability

3(d) New Forms without enhanced efficacy.

(Chennai High Court on Gleevec)

3(p) Traditional Knowledge.

GNAs

non patentability7
Non-patentability

Compulsory for microorganisms and life forms including plants –

 Disclosure of Origin (Budapest Treaty)

 Benefit Sharing

 Biodiversity Act

(The Biological Diversity Act, 2002)

GNAs

plant patentability
Plant Patentability

US – Plant Patents

India – Plant Varieties Protection Act

(The Protection of Plant Varieties and Farmers Rights Act, 2001)

(http://agricoop.nic.in)

GNAs

patentability criteria9
Patentability Criteria

Anticipation –

India – rigid on single Prior art-based anticipation

Insists “mosaic” of Prior arts are not “anticipation”

PCT/US – Often cites close prior arts as affecting Patentability

GNAs

unity of invention
Unity of Invention

India – more liberal on

group of inventions

USPTO – very restrictive

Insists on electing one invention / Filing Divisionals

Even Process / Composition / use as separate inventions

GNAs

timelines
Timelines

India – Rigid on extensions

Normally extensions not granted

US – very liberal

protracted prosecution

Court order based fast tracking

GNAs

publication public domain information
Publication / Public Domain Information

India – Bibliography

US/EU – Full Patent

US – Total Transparency – “Public Pair”

EU – Legal Status

Patent Family

GNAs

patent office procedures
Patent Office Procedures

India – Post dating

(allows) Complete to Provisional

Cognates

Addition Patents

US – Liberal procedures

(allows) C.I.Ps

Amendments/RCE

GNAs

us vs india
US vs. INDIA

US grants

  • Patent Term extensions/adjustments
  • Data Exclusivity
  • Orange Book Listings
  • 180 Day Exclusivity

INDIA does not grant any of above

GNAs

indian patent regulatory
Indian Patent/Regulatory

Unlike USA/Europe, the Patent Regulatory link has not been formalised.

Generic launch friendly Indian policy

GNAs

oppositions
Oppositions

USA –

Opportunity to protest “Amicus Curie” in litigation

India (Recent Gleevec Case) –

Pre-grant Opposition

Post-grant Opposition

Counterclaim for Revocation

Government use option

GNAs

research exemptions
Research Exemptions

USA –

Used to be rigid

Under Bolar exemption (Hatch - Waxman)

Became liberal after US Supreme Court

Judgement on Merck vs. Integra

Contrast with Madey vs. Duke

India –

Research & Educational Exemptions

More liberal & broad

Sec. 47A – Educational

Sec. 107A – Research for ANDA

GNAs

compulsory licence
Compulsory Licence

USA –

28 USC 1498

India –

Sec. 63 to 94 & 92A

Govt. use – Sec. 99 to 103

(Recent Natco Case)

GNAs

patent challenges
Patent Challenges

USA –

Para IV Challenge

Recent Developments

Caraco vs. Forest

MedImmune vs. Genentech

India –

Infringement based litigation

Roche vs. Cipla on Tarceva

GNAs

injunctions summary suits
Injunctions / summary suits

India –

Frequency increasing

Recent Case –

Garware Wall Ropes Ltd. V. M/s. TECHFAB India (A "Synthetic" Judgment)

Facts of the CaseThe present case involves two manufacturers of synthetic ropes, twines, yarns and various rope products such as gabions. The first of them are the appellants/patentee Garware Wall Ropes Ltd. and the other, the respondents M/S Techfab India who have been accused of infringing the appellants\' patent on a certain “Synthetic Rope Gabion” (referred to as SRG in short). The judgment doesn’t explain what exactly are the features of SRG but for a vague mention that it is a gabion which uses synthetic rope, as opposed to a metal wire, as the meshing element that forms the outer body of the gabion (neither is the specification of the patent available on any of the patent websites). Accordingly, the appellants claim that the use of synthetic rope imparts greater flexibility to the gabion, which helps overcome the disadvantages associated with a rigid metal frame.

… Contd

GNAs

injunctions summary suits contd
Injunctions / summary suits(contd….)

According to the appellants, an agent of theirs in Gujarat informed them of the infringement of their patent by the respondents early in October 2005 and on the 17th of the same month, an infringement suit along with a prayer for ad-interim relief was filed in the District Court, Surat, which was granted ex-parte the next day. Following this, the respondents filed for an appeal in the Gujarat High Court against the injunction, exactly a week after the grant of the injunction. The following day, the injunction was vacated by a Single Judge, with the observation that “in case the respondents feel that the impugned gabions are different than (from) the patented SRG invention of the appellant, the respondents were free to manufacture and sell the impugned gabions”. The respondents were then directed to maintain accounts of such manufacture and sale.Consequent to the filing of a counterclaim by the respondents for revocation of the patent, the suit was transferred to the High Court (under proviso to s.104) along with an application by the appellants to quash the Single Judge’s order.

GNAs

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